Cleared Traditional

FACEPLATE ITE HEARING AID MODEL 28A (K910901) - FDA 510(k) Clearance

Class I Ear, Nose, Throat device.

K910901 · Telex Communications, Inc. · Ear, Nose, Throat device
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May 1991
Decision
86d
Days
Class 1
Risk

K910901 is an FDA 510(k) clearance for the FACEPLATE ITE HEARING AID MODEL 28A. Classified as Face Plate Hearing Aid (product code LRB), Class I - General Controls.

Submitted by Telex Communications, Inc. (Minneapolis, US). The FDA issued a Cleared decision on May 30, 1991 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3300 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Telex Communications, Inc. devices

Submission Details

510(k) Number K910901 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1991
Decision Date May 30, 1991
Days to Decision 86 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 89d · This submission: 86d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LRB Face Plate Hearing Aid
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.3300
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.